NA 395.46Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982200334), received between Mar 8, 2019 and Apr 29, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Break

  IT WAS REPORTED ON (B)(6), 2026 THAT THE WING NUTS HAVE BROKEN IN 4 OF THE SLEEVES FOR DISTRACTORS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25030932 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED ON (B)(6) 2026 THAT THE WING NUTS HAVE BROKEN IN 4 OF THE SLEEVES FOR DISTRACTORS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027002 ↗
• MalfunctionAug 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, THE UNKNOWN THREADED TROCAR THREADS WAS DAMAGED. PROCEDURE WAS DELAYED FOR FOUR(4) MINUTES. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 85MM FOR MEDIUM DISTRACTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366809 ↗
• MalfunctionApr 29, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE WING NUT WAS BROKE ON HOLDING SLEEVE FOR MEDIUM DISTRACTOR. SURGICAL DELAY WAS UNKNOWN. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10010197 ↗
• MalfunctionMar 8, 2019Break; Break

  IT WAS REPORTED THAT DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE SURGERY ON (B)(6) 2019, THE WING NUT BROKE ON MEDIUM DISTRACTOR SLEEVE PIN AND STUCK IN SLEEVE. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 85MM FOR MEDIUM DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8404526 ↗